| CTRI Number |
CTRI/2025/02/081303 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Pilot study ] |
| Study Design |
Other |
|
Public Title of Study
|
Nutool therapy in stress management |
|
Scientific Title of Study
|
Effect of Nutool therapy in stress management. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Shoaib |
| Designation |
Assistant professor |
| Affiliation |
Ajmal Khan tibbiya college |
| Address |
Department of Ilaj-bit-Tadbeer, Faculty of Unani Medicine, Aligarh Muslim University,
Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9411491568 |
| Fax |
|
| Email |
drmshoaib77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Shoaib |
| Designation |
Assistant professor |
| Affiliation |
Ajmal Khan tibbiya college |
| Address |
Department of Ilaj-bit-Tadbeer, Faculty of Unani Medicine, Aligarh Muslim University,
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9411491568 |
| Fax |
|
| Email |
drmshoaib77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Shoaib |
| Designation |
Assistant professor |
| Affiliation |
Ajmal Khan tibbiya college |
| Address |
Department of Ilaj-bit-Tadbeer, Faculty of Unani Medicine, Aligarh Muslim University,
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9411491568 |
| Fax |
|
| Email |
drmshoaib77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aligarh Muslim University , 202002,Aligarh, Uttar Pradesh, India. |
|
|
Primary Sponsor
|
| Name |
Ajmal Khan tibbiya college |
| Address |
Ajmal Khan tibbiya college, Aligarh Muslim University, Aligarh, 202002, Uttar Pradesh, India. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohd Saad Khan |
Ajmal Khan Tibbiya College and Hospital |
Department Of Ilaj bit Tadbeer, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
7409776983
saadkhancbi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F430||Acute stress reaction, (2) ICD-10 Condition: F430||Acute stress reaction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
The patients for the study will be selected from the following criteria:
1. Diagnosed cases of stress.
2. Age between 20 and 45 years of age of both sexes.
3. Patients willing to give informed written consent. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1. Age below 20 and above 45 years of age.
2. Patients who refuse to sign the consent.
3. Patients with concurrent systemic illness.
4. Patients on any other medications.
5. Pregnant and lactating patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in perceived stress scale (PSS) in every 2 weeks for 8 weeks |
Changes in perceived stress scale (PSS) in every 2 weeks for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Objective parameters assessed clinically by Psychiatrist |
After 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background and purpose of the research: Stress is a prevalent mental health issue affecting all ages worldwide and there is no effective cure in conventional medicine that is why we selected this regimen to evaluate the efficacy of nutool therapy with arq-e-gulab in stress management |